Veru Inc. Q4 FY2025 earnings call

• Veru's obesity program update: The Phase IIb QUALITY clinical trial showed enobosarm 3-milligram plus semaglutide preserved lean mass, increased fat loss, and improved physical function. The Phase IIb PLATEAU trial will target patients with obesity, BMI ≥35, age ≥65, starting in Q1 2026.
• Financial highlights: As of September 30, 2025, cash and cash equivalents were $15.8 million. A public offering in October 2025 raised approximately $23.4 million in net proceeds. Research and development costs increased, while selling, general, and administrative expenses decreased, with gains from asset sales.

Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for cardiometabolic and inflammatory diseases, with drug candidates enobosarm and sabizabulin. Financially, on December 30, 2024, Veru sold the FC2 Female Condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after costs, with a loss on the sale of $4.1 million. Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year due to expenses related to the Phase IIb QUALITY clinical study for enobosarm.

• The Phase IIb PLATEAU clinical trial is expected to begin in Q1 2026, with an interim analysis for lean and fat mass change via DEXA in Q1 2027.
• Cash as of the financial statement issuance date is sufficient to fund operations through the interim analysis of the PLATEAU study.

• Regulatory uncertainties in obesity drug development, as the regulatory landscape for muscle preservation drugs for obesity is evolving.
• Competitive landscape with other companies' similar drugs, which may present challenges.
• Intellectual property risks related to patent protection for enobosarm formulations.

Q: William Wood inquired about GLP-1 inclusion in the PLATEAU study and Phase III transition.

A: Mitchell Steiner explained they'll use one GLP-1 agonist (tirzepatide or semaglutide), and the Phase IIb is a mini Phase III to guide Phase III design, considering physical function and body composition endpoints.

Q: Rohan Mathur asked about flexibility in regulatory discussions around weight loss and muscle function.

A: Mitchell Steiner noted there are multiple ways to measure physical function (stair climb, clinical questionnaires, mobility disability assessment) to show clinical meaningfulness for regulatory approval.